Moxifloxacin HEC 400 mg film-coated tablets

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

MOXIFLOXACIN HCL

Boleh didapati daripada:

MEDISPEC (M) SDN.BHD

INN (Nama Antarabangsa):

MOXIFLOXACIN HCL

Unit dalam pakej:

1 x 5 Tablets; 1 x 7 Tablets; 1 x10 Tablets; 2 x 7 Tablets; 3 x 10 Tablets; 12 x 10 Tablets; 5 x 10 Tablets

Dikeluarkan oleh:

Sunshine Lake Pharma Co., Ltd.

Risalah maklumat

MOXIFLOXACIN HEC 400MG FILM-COATED
TABLET
Moxifloxacin (400mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Moxifloxacin HEC_
is used for
2.
How
_Moxifloxacin HEC_
works
3.
Before you use
_Moxifloxacin HEC_
4.
How to use
_Moxifloxacin HEC_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Moxifloxacin HEC_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _MOXIFLOXACIN HEC_ IS USED FOR
_Moxifloxacin HEC_
is used in patients 18
years of age and older for treatment of
bacterial
infections
caused
by
bacteria
susceptible to moxifloxacin.
HOW _MOXIFLOXACIN HEC_
WORKS
_Moxifloxacin HEC _
works by killing
bacteria that cause infections.
BEFORE YOU USE _MOXIFLOXACIN HEC_
-
_When you must not use it _
Do not take
_Moxifloxacin-HEC_
:

If you are allergic to moxifloxacin,
any other quinolone antibiotics or any
of
the
other
ingredients
of
this
medicine.

If you are under 18 years of age.

If you have previously had problems
with
your
tendons
related
to
treatment with quinolone antibiotics

If you were born with or have any
condition
with
abnormal
heart
rhythm, a salt imbalance in the blood
(especially low levels of potassium in
the blood), a very slow heart rhythm,
heart failure, a history of abnormal
heart rhythms, or you are taking other
medicines
that
result
in
abnormal
ECG changes.

If you have a severe liver disease or
increased liver enzymes.
_ _
_ _
-
_Pregnancy and lactation _
Do not take
_Moxifloxacin HEC_
if you
are pregnant, trying to get pregnant or
think you may be pregnant.
Do not take
_Moxifloxacin HEC_
if you
are breast-feeding. Ask your doctor
or
pharmacist
for
advice
before
taking any medicine.
_ _
-
_Before you start to use it _
Talk
to
your
doctor
before
taking
_Moxifloxacin-HEC_

If
you
have
any
heart
rhythm
conditions.

If
you
suffer
from
epilepsy
or
a
condition which makes you likely to
have convulsions.

If you have or have ever had any
mental health problems.

If you

Ciri produk

PRODUCT NAME
Moxifloxacin HEC 400 mg film-coated tablets
COMPOSITION
Each film-coated tablet contains 400 mg moxifloxacin (as hydrochloride
monohydrate).
DOSAGE FORM
Film-coated tablet.
PRODUCT DESCRIPTION
White or off-white oblonged film-coated tablets, debossed “S9” on
one side while blank on the
other.
PHARMACODYNAMICS
Pharmacotherapeutic group: Quinolone antibacterials, fluoroquinolones,
ATC code: J01MA14
Mechanism of action
_ _
Moxifloxacin is
_ _
activity against a wide range of Gram-positive and Gram-negative
pathogens.
The
bactericidal
action
of
moxifloxacin
results
from
the
inhibition
of
both
type
II
topoisomerases (DNA gyrase and topoisomerase IV) required for
bacterial DNA replication,
transcription and repair. It appears that the C8-methoxy moiety
contributes to enhanced activity
and lower selection of resistant mutants of Gram-positive bacteria
compared to the C8-H
moiety. The presence of the bulky bicycloamine substituent at the C-7
position prevents active
efflux, associated with the
_nor_
A or
_pmr_
A genes seen in certain Gram-positive bacteria.
Moxifloxacin exhibits a concentration dependent killing rate.
Mechanism of resistance
Resistance
mechanisms
that
inactivate
penicillins,
cephalosporins,
aminoglycosides,
macrolides and tetracyclines do not interfere with the antibacterial
activity of moxifloxacin.
Other
resistance
mechanisms
such
as
permeation
barriers
(common
in
_Pseudomonas _
_aeruginosa_
) and efflux mechanisms may also effect susceptibility to
moxifloxacin.
Moxifloxacin is a poor substrate for active efflux mechanisms in
Gram-positive organisms.
Moxifloxacin inhibits both topoisomerase II and IV with similar
activity in some Gram-
positive bacteria, such bacteria may be resistant to other quinolones,
but susceptible to
moxifloxacin.
_ _
Microbiological Susceptibility
_ _
The prevalence of acquired resistance may vary geographically and with
time for selected
species and local information of resistance is desirable, particularly
when treating severe
infections. As necessary, expert